FDA Adverse Event
Death
Summary report: N
SIMPLEX BONE CEMENT
MDR report key: 2431569
·
Received January 30, 2012
Report
- Report Number
- 1818910-2012-02704
- Event Type
- Death
- Date Received
- January 30, 2012
- Date of Event
- May 31, 2011
- Report Date
- August 5, 2012
- Manufacturer
- DEPUY CMW
- Product Code
- LOD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.
Description of Event or Problem · 1
HAPPENED WHILE INSERTING THE FINAL FEMORAL IMPLANT AFTER RETROGRADE CEMENT FILLING INTO THE FEMORAL CANAL. THE SURGEON CLAIMS THAT PATIENT'S DEATH HAPPENED FOLLOWING THE USE OF THE REPORTED PRODUCT.
Description of Event or Problem · 1
DURING INVESTIGATION FOUND THAT THE BONE CEMENT WAS MANUFACTURED BY OTHERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX BONE CEMENT | BONE CEMENT | LOD | DEPUY CMW | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |